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CompletedNCT05088304Updated Oct 21, 2021

GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer

An observational study in Cancer of Stomach, Cancer of Esophagus and Malnutrition, sponsored by Jinling Hospital, China. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-21.

Sponsored by Jinling Hospital, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
205
Ages
18 Years and older
Sex
All
01

Study summary

The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria.

Read the detailed description

The GLIM criteria of malnutrition as a consensus lack of optimal combination in clinical validation. After the publication of the GLIM consensus, few studies have examined the effect of reduced FFMI on the clinical prognosis of patients with esophagogastric cancer, and whether the FFMI can be used as an effective diagnostic criterion of malnutrition in esophagogastric cancer needs to be further studied.

Therefore, the present study aims were to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the GLIM consensus for malnutrition.

02

Conditions studied

  • Cancer of Stomach
  • Cancer of Esophagus
  • Malnutrition
  • Muscle Loss

Keywords

  • FFIM
  • GLIM
  • Cancer
  • Postoperative complications
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 205 is close to the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery)

Inclusion criteria

Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery); NRS2002≥3; Preoperative BIA examination was performed.

Exclusion criteria

Exclusion Criteria:

Discharged from a hospital within 24 hours; No BIA examination and not suitable for BIA examination (such as ascites, edema, amputation and pace-maker); Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin>3mg/dL) ; Renal insufficiency (serum creatinine>1.5mg/dL); Emergency operation; Pregnancy; Missing the postoperative information follow-up data.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
205 participants (actual)
Patient registry
No

Groups and cohorts

  • The normal FFMI group

    The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, \</≥15 kg/m2 for females and \</≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the normal FFMI group (FFMI ≥17 kg/m2 for male and FFMI ≥15 kg/m2 for female).

    Other: no intervention

  • The low FFMI group

    The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, \</≥15 kg/m2 for females and \</≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the low FFMI group (FFMI \<17 kg/m2 for male and FFMI \<15 kg/m2 for female).

    Other: no intervention

Interventions

  • Otherno intervention
06

What researchers measure

Primary outcomes

  1. postoperative complications

    postoperative complications (infectious complications and noninfectious complications)

    Time frame: Within 60 days after surgery

Secondary outcomes

  1. length of stay (LOS)

    length of stay (LOS)

    Time frame: Within 60 days after surgery

  2. wound healing time

    wound healing time

    Time frame: Within 60 days after surgery

  3. postoperative antibiotic time

    postoperative antibiotic time

    Time frame: Within 60 days after surgery

  4. nutritional status

    nutritional status ( such as: weight,albumin,prealbumin)

    Time frame: up to 4 weeks

  5. hospitalization cost

    hospitalization cost(including: surgery and medicine costs)

    Time frame: Within 60 days after surgery

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05088304
Lead sponsor
Jinling Hospital, China
Collaborators
Jiangsu Cancer Institute & Hospital, Subei People's Hospital of Jiangsu Province, Peking Union Medical College
Responsible party
Wang Xinying (Professor, Jinling Hospital, China) — Principal investigator
First posted
Oct 21, 2021
Start date
Sep 1, 2015
Primary completion
Jun 1, 2018
Completion
Jul 1, 2018
Last update
Oct 21, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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